K770665 is an FDA 510(k) clearance for the VALVE, PRESSURE, DEMAND. This device is classified as a Bottle, Collection, Breathing System (calibrated) (Class II - Special Controls, product code CBD).
Submitted by Mcgaw Respiratory Therapy (Mchenry, US). The FDA issued a Cleared decision on April 15, 1977, 7 days after receiving the submission on April 8, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K770665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1977 |
| Decision Date | April 15, 1977 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | CBD — Bottle, Collection, Breathing System (calibrated) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |